Meglumine sodium succinate.
A clear colorless solution.
Composition: See Table 1.
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Therapeutic Category: Solutions affecting the electrolyte balance. ATC Code: B05BB.
Pharmacology: Pharmacodynamics: REAMBERIN possesses anti-hypoxic and antioxidant properties, rendering positive effect on aerobic processes in the cell, reducing free radical generation, restoring cell action potential and promoting recycling of fatty acids and glucose by cells.
The medicinal product activates enzymatic processes of the Krebs cycle and promotes recycling of fatty acids and glucose by cells, normalizes acid-base balance and blood gas structure. The solution has a moderate diuretic effect.
Pharmacokinetics: During intravenous administration REAMBERIN is quickly utilized and not accumulated in the organism.
REAMBERIN is used as an antioxidant for supporting treatment of adult patients with acute viral hepatitis, purulent peritonitis, and for children over 1 year with rotavirus infection.
In adults: REAMBERIN should be administered intravenously by continuous infusion at a rate of 1-4.5 mL/min (up to 90 drops/min). For adults the daily dose is 400-800 mL.
Infusion speed and dosage are estimated based on patient condition.
The treatment course is up to 10 days.
In children: REAMBERIN should be administered intravenously by continuous infusion at a rate of 1-4 mL/min (up to 80 drops/min). For children the daily dose is 6-10 mL/kg of body weight, not to exceed 400 mL.
The treatment course is up to 7 days.
In the case of missing the dose it is recommended to continue therapy on the next day in the same dosage. The treatment course in this case can be extended.
No cases of overdose with REAMBERIN were registered or reported. Due to its rapid utilization in organism the overdose with REAMBERIN is unlikely. Do not use REAMBERIN in higher doses than recommended.
Known sensitization to any of the components of this medicinal product, traumatic brain edema, acute renal failure, chronic kidney disease (stage 5, glomerular filtration rate less than 15 mL/min), pregnancy, breastfeeding.
A decrease in plasma glucose level and alkalization of urine can occur since the medicinal product promotes aerobic respiration in the organism. In patients with diabetes or impaired glucose tolerance, monitoring of blood glucose level is required.
REAMBERIN should be used with great care in patients with alkalosis and renal failure.
Should color change and precipitate occur, the use of medicinal product is not allowed.
Effects on Ability to Drive and Use Machine: There is no proven influence of the medicinal product on ability to drive or operate machinery. To drive and operate machinery is not recommended during the course of treatment with REAMBERIN.
REAMBERIN is not recommended during pregnancy and breastfeeding due to the absence of clinical studies in these groups of patients.
If given too fast the following adverse reactions can be developed classified according to their frequency of development as follows: very common (frequency of adverse drug reaction is ≥1/10); common (frequency of adverse drug reaction is ≥1/100-<1/10); uncommon (frequency of adverse drug reaction is ≥1/1000-<1/100); rare (frequency of adverse drug reaction is ≥1/10000-<1/1000); very rare (frequency of adverse drug reaction is <1/10000); rate is unknown (frequency of adverse drug reaction can't be determined on the basis of the obtained data). (See Table 2.)
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To avoid adverse reactions, it is recommended to comply with the dosing regimen and the rate of drug administration.
If adverse reactions occur, the rate of infusion should be lowered.
REAMBERIN is compatible with antibiotics, water-soluble vitamins, and glucose solution.
REAMBERIN is compatible with medicinal products, containing phosphates, sulfates or tartrates.
Do not recommend mixing of REAMBERIN in bottle with other preparations. Simultaneous intravenous administration of REAMBERIN and calcium preparations is prohibited due to possible precipitation of calcium succinate.
Instructions and Special Precautions for Handling and Disposal: Before administration, REAMBERIN should be inspected visually. Do not use REAMBERIN if there is a color change or precipitate occurs.
If the patient has unused or expired REAMBERIN, he or she should dispose of the medicine in the following manner. Open a bottle, dispose of the content via wastewater and the glass bottle via special household waste for glass.
Store in a light protected place at temperature below 30°C.
Shelf life: 5 years. Administration of the medicinal product with expired date is prohibited.
B05BB - Solutions affecting the electrolyte balance ; Used in I.V. solutions.
Reamberin soln for infusion
400 mL x 1's (Rp400,000/boks)
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